Clinical Trial of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain

NCT06393088 | Completed Results FDA Device

• 1 other identifier: IR_REHAB_Clinical_Trial
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a trial to measure the effectiveness and safety of the invisa-RED® IR REHAB device. The researchers will compare the muscle and joint pain relief of participants who are treated with the real machine, to those treated with a non-working "look-a-like" device. If there is a significant difference of pain relief between those treated with the real machine and those treated with the 'look-a-like' device and no safety issues are discovered, the researchers will be able to assume the IR REHAB device is safe and effective for the treatment of muscle and joint pain.

Conditions

Nociceptive Pain; Musculoskeletal Pain

Keywords

Low level laser therapy; photobiomodulation; dual frequency; red; near infrared; light

Outcome Measures

Primary Outcomes (1)

• Measured Change in the Participants Pain Levels

  Participants pain levels will be measured using a visual analog scale of 0-100mm where a smaller number indicates a lower perceived pain level and a larger number indicates a higher level of pain. The participant will personally manipulate a visual analog scale with a manual slide indicator to record their pain levels

  Participants pain levels will be recorded over a period of three weeks.

Study Arms (2)

IR REHAB Device

EXPERIMENTAL

Participants will receive 6 treatments of 15 minutes each with an active IR REHAB device over the period of three weeks.

Device: IR REHAB

Sham Device

SHAM COMPARATOR

Participants will receive 6 treatments of 15 minutes each with a disabled (sham) IR REHAB device over the period of three weeks.

Device: Sham

Interventions

IR REHAB DEVICE

Participants undergo therapy sessions with active, dual frequency, low level laser therapy device

IR REHAB Device

Sham DEVICE

Participants undergo therapy sessions with disabled device producing no laser energy

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The number of participants is projected to be thirty (30).
• There will be an equitable distribution of male and female participants.
• Women who are pregnant, trying to get pregnant, or nursing will be excluded from the study, as they should not receive Low-level Laser Therapy (LLLT). There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating such individuals.
• The participants will be 18 years or older.
• The ethnicity of the participants will be equitably distributed.

You may not qualify if:

• If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child.
• Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device.
• People suffering from infectious and acute disease such as a fever should not use this device.
• People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device.
• Person with a history of lentigines, an autoimmune vascular disease that causes color changes in the legs or arms due to obstruction or stenosis of blood vessels.
• A person with a history of erythema, an acquired, long-lasting reticulocyte red and pigmented rash, caused by persistent or repeated exposure to intense heat or infrared radiation.
• Persons who are susceptible to or have a history of herpes in the treatment area
• Anyone who has experienced problems subsequent to previous laser treatments
• People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and light sensitive persons should not use this device.
• Use of laser light therapy in the ears, nose, eye, or throat is not recommended.
• Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar formation, or healing problems should not undergo laser light therapy.
• Individuals with active infections, open lesions, hives, herpetic lesions, cold sores, or tattoos and permanent make-up in the area of treatment should not undergo laser light therapy.
• People who have used isotretinoin (commonly known as Accutane), tetracycline, St. John's Wort, or any photo sensitizing drugs in the last year should not undergo laser light therapy.
• Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should not undergo laser light therapy.
• Individuals who have pacemakers or other electro-stimulation devices surgically implanted should not undergo laser light therapy.

Sponsors & Collaborators

• IR Technology, LLC: lead

Study Sites (1)

Abbycare Clinic

Woodstock, Georgia, 30189, United States

Location

Related Publications (1)

• El-Tallawy SN, Nalamasu R, Salem GI, LeQuang JAK, Pergolizzi JV, Christo PJ. Management of Musculoskeletal Pain: An Update with Emphasis on Chronic Musculoskeletal Pain. Pain Ther. 2021 Jun;10(1):181-209. doi: 10.1007/s40122-021-00235-2. Epub 2021 Feb 11.

  PMID: 33575952 BACKGROUND

MeSH Terms

Conditions

Nociceptive Pain; Musculoskeletal Pain; Erythema

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Results Point of Contact

• Title: Consulting Director of Clinical Trials
• Organization: IR Technology LLC

andyn@invisaredtech.com

404 915-5938

Study Officials

• Ajibole Abatunde, MD

  Midnight Rose LLC dba Abbycare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All individuals participating in the trial will be assigned a participant number. Subsequently all clinical records and reports will reference only the participant number, ensuring that participants remain anonymous. Because of the low number of trial participants, only paper records will be maintained for all clinical and personal data. Records will be kept in locked storage and physical access will only be on a need to know basis. A participants' personal data correlating the participating individuals name and the trial participants Identifying Number will only be available to the principal investigator, clinical staff, and the trial administrator. All analytics will be performed on securely encrypted devices using only data masked or redacted of any personal information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial will compare results between two groups; the first will be treated using the invisa-RED Technology IR REHAB and the second group with a sham device. The trial will be conducted employing a single blind study methodology; participants will not know to which trial group they have been assigned. Participants will undergo six (6) therapy sessions each using a standardized 15 minute protocol. At each of the therapy sessions; the participant will be asked to record their pain level before the treatment session and then in the same manner after the treatment using a Visual Analog Scale (VAS). The results from the two groups will be statistically analyzed to determine the efficacy of the invisa-RED Technology IR REHAB as an adjunctive therapy for musculoskeletal pain. Any medical errors will be included in the statistical analysis.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: July 22, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)